AccessGUDID - DEVICE: LEADER, pen needles (00096295138788)

GUDID

Device Identifier (DI) Information

Brand Name: LEADER, pen needles
Version or Model: 33G x 4 mm
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8472
Company Name: HTL STREFA S A

Primary DI Number: 00096295138788
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 422528088 *Terms of Use

Device Description: Single LEADER pen needles, intended to be used with a pen injector device for the subcutaneous injection of insulin.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
44127	Autoinjector needle	A device designed for the parenteral administration of a drug contained in a cartridge that forms part of, is attached to, or inserted into an autoinjector (drug pen injector). It is used by persons requiring regular, self-administrated dosages of insulin, hormones, or other pharmaceuticals. This device will typically be constructed as a double-ended, stainless steel needle of various sizes that is fixed to a threaded hub of plastic to which the drug pen injector is connected. This device is packaged in a sealed sterility barrier, and might include needle shielding safety features to reduce the risk of needle stick injury. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMI	Needle, Hypodermic, Single Lumen

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -10 and 45 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 33G x 5/32" \| 0.20mm x 4mm

Device Record Status

Public Device Record Key: ee945f69-67d8-4c46-b9bf-3a6071bd4fd5
Public Version Date: November 14, 2024
Public Version Number: 2
DI Record Publish Date: January 13, 2020